Mix and Match vakcíny COVID-19 pro bezpečnost a imunogenicitu (MOSAIC)
Imunogenicita a nežádoucí účinky po imunizaci (AEFI) s alternativními plány vakcín proti COVID-19 v Kanadě: je „Mix and Match“ druhé dávky (MOSAIC-1;CT24a) a třetí dávky (MOSAIC-2;CT24b) bezpečné a imunogenní ?
The main goals of this study are to assess the immune response and safety of two different vaccines for first, second, third and fourth doses as well as for differing intervals between the first and second dose of two-dose vaccines.
Přehled studie
Postavení
Podmínky
Detailní popis
For dose 1 and 2, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) are two dose vaccines which were studied in schedules of either 0 and 21 days or 0 and 28 days, respectively. The ChAdOx1 nCOV-19 (Astra-Zeneca) adenovirus-vectored vaccine is authorized to be given in two doses one month to 12 weeks apart. We will compare the interval 0, 28 days to a 0, 112 days (16 weeks) schedule, and assess the immunogenicity of both heterogeneous and heterologous second doses using the Canadian schedule.
For dose 3, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) and plant-based virus-like particle (Medicago Covifenz) are anticipated to be administered 6 months apart. We will assess the immunogenicity of both heterogeneous and heterologous third doses using the Canadian schedule.
For dose 4, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) and plant-based virus-like particle (Medicago Covifenz) are anticipated to be administered 3 months apart. We will assess the immunogenicity of both heterogeneous and heterologous third doses using the Canadian schedule.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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British Columbia
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Kamloops, British Columbia, Kanada
- Royal Inland Hospital
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Penticton, British Columbia, Kanada
- Penticton Regional Hospital
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Vancouver, British Columbia, Kanada, V5Z 4H4
- BC Children's Hospital Research Institute
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Manitoba
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Winnipeg, Manitoba, Kanada
- Children's Hospital Research Institute of Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Kanada
- Canadian Center for Vaccinology
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Ontario
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Ottawa, Ontario, Kanada
- Ottawa Hospital Research Institute, University of Ottawa
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Quebec
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Montreal, Quebec, Kanada, H9H 4Y6
- McGill University Health Centre Vaccine Study Centre
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Québec, Quebec, Kanada
- CHU de Québec, Université Laval
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Participant is willing and able to give written informed consent to participate in the study
- Age 18 years of age or older in good health or with mild or moderate stable co-morbidities at the time of enrolment
- Able and willing to complete all the scheduled study procedures during the whole study follow-up period
- If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the final dose of study vaccine (Please refer to the definition section for a description of child-bearing potential and adequate contraception)
- MOSAIC-1 Vaccine-exposed subgroups: have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1 (documentation of receipt required)
- MOSAIC -1 Vaccine naïve subgroups: have not received an authorized COVID-19 vaccine at any time
- MOSAIC-2 participants have received two doses of COVID-19 vaccines authorized in Canada ≥6 months prior to study vaccine administration (documentation of receipt required)
- MOSAIC-3 participants have received three doses of COVID-19 vaccines authorized in Canada ≥3 months prior to study vaccine administration (documentation of receipt required)
Exclusion Criteria:
- Inability or unwillingness of participant or legally acceptable representative to give written informed consent
- Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
- Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
- Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine and for one month after the last dose of study vaccine
- Allergy to any study vaccine or any active substance in a study vaccine
- Bleeding disorder or history of significant bleeding following IM injections or venipuncture
- Continuous use of anticoagulants
- A history of anaphylaxis to a previous vaccine
- Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine
- MOSAIC-1: History of laboratory-confirmed COVID-19 disease prior to enrolment by participant report
- Administration of a live virus vaccine within 4 weeks prior to study vaccine receipt.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Group 1: Moderna, Moderna - 28 Days apart
Participants will be blinded and receive two doses (0.20 mg/mL each) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle 28 days apart. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
Second injection administered 28 days post first injection |
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Aktivní komparátor: Group 2: Moderna, Moderna - 112 days apart
Participants will be blinded and receive two doses (0.20 mg/mL each) of mRNA-1273 SARS-CoV-2 vaccine at 0.20 mg/mL via intramuscular injection in the deltoid muscle 112 days apart. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
Second injection administered 112 days post first injection |
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Aktivní komparátor: Group 3: Moderna, Pfizer/BioNTech - 28 days apart
Participants will be blinded and receive one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3mL) of BNT162b2 vaccine after 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
Second injection administered 28 days post first injection A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 4: Moderna, Pfizer/BioNTech - 112 days apart
Participants will be blinded and receive one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3mL) of BNT162b2 vaccine after 112 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
Second injection administered 112 days post first injection A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apart
Participants will be blinded and receive two doses (0.3mL each) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle 28 days apart. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Second injection administered 28 days post first injection A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apart
Participants will be blinded and receive two doses (0.3mL each) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle 112 days apart. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Second injection administered 112 days post first injection A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 7: Pfizer/BioNTech, Moderna - 28 days apart
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
Second injection administered 28 days post first injection A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 8: Pfizer/BioNTech, Moderna - 112 days apart
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 112 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
Second injection administered 112 days post first injection A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 9: Astra Zeneca, Moderna - 28 days apart
Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S [recombinant] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
Second injection administered 28 days post first injection A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
Ostatní jména:
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Aktivní komparátor: Group 10: Astra Zeneca, Moderna - 112 days apart
Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S [recombinant] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 112 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
Second injection administered 112 days post first injection A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
Ostatní jména:
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Aktivní komparátor: Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart
Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S [recombinant] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3 mL) of BNT162b2 vaccine after 28 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Second injection administered 28 days post first injection A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
Ostatní jména:
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Aktivní komparátor: Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apart
Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S [recombinant] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3 mL) of BNT162b2 vaccine after 112 days. Vaccine-exposed participants will only be blinded to, and receive, the second injection. |
Second injection administered 112 days post first injection A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
Ostatní jména:
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Aktivní komparátor: Group 1b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle. |
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 2b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
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Aktivní komparátor: Group 3b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
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Aktivní komparátor: Group 4b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle. |
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 5b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
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Aktivní komparátor: Group 6b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle. |
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 7b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle. |
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 8b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
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Experimentální: Group 9b
Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle. |
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Ostatní jména:
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Aktivní komparátor: Group 1c
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle. |
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 2c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle. |
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Ostatní jména:
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Aktivní komparátor: Group 3c
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
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Aktivní komparátor: Group 4c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle. |
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Ostatní jména:
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Aktivní komparátor: Group 5c
Participants will be blinded and receive either one dose (0.3mL) of BNT162b2 or one half dose (0.25mL) of mRNA-1273 via intramuscular injection in the deltoid muscle. |
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Ostatní jména:
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Ostatní jména:
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Aktivní komparátor: Group 6c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle. |
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Ostatní jména:
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Experimentální: Group 7c
Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle. |
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Antibody response to SARS-CoV-2 S protein after 2 doses
Časové okno: Day 56
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The co-primary outcome for the non-inferiority comparison of 0, 28-day schedules with heterologous second dose is the immune response to SARS-CoV-2 at day 56 (28 days after the second dose of vaccine) based on anti-spike antibody titers. |
Day 56
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Antibody response to SARS-CoV-2 S protein after 2 doses
Časové okno: Day 140
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The co-primary outcome for the non-inferiority comparison of schedules in which the timing of the second dose of vaccine is different (0, 28 days v 0, 112 days) is the immune response to SARS-CoV-2 at day 140 (28 days after the last dose in the 0, 112 day schedule) based on anti-spike antibody titers. |
Day 140
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Antibody response to SARS-CoV-2 S protein after 3 doses
Časové okno: Day 28
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To determine if a vaccination schedule with a heterologous third dose of a COVID-19 vaccine induces a non-inferior serum immune response to SARS-CoV-2, compared to a third dose/booster with a homologous vaccine. |
Day 28
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Antibody response to SARS-CoV-2 S protein after 4 doses
Časové okno: Day 28
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To determine if a vaccination schedule with a heterologous fourth dose of a COVID-19 vaccine induces a non-inferior serum immune response to SARS-CoV-2, compared to a third dose/booster with a homologous vaccine. |
Day 28
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Durability of antibody response to SARS-CoV-2 S over 12 months after 2 doses
Časové okno: Baseline and Days 28, 56, 112, 140, 365
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Assess durability of immune responses in each study group over 12 months based on anti-spike antibody titers and pseudoneutralization assay. |
Baseline and Days 28, 56, 112, 140, 365
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Pseudoneutralization assay, T cell testing, Antibody dependent cellular cytotoxicity (ADCC), Antibody avidity, RNA seq after 2 doses
Časové okno: Days 28, 56, 112, 140, 365
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Characterization of the immune response to COVID-19 vaccines in schedules with 0, 28 days versus 0, 112 days dosing and heterologous schedules to day 365. |
Days 28, 56, 112, 140, 365
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Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 2 doses
Časové okno: From time of first study injection through Day 365.
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Description of safety outcomes over 12 months post-vaccination including SAEs (serious adverse events), provincially reportable AEFIs (adverse events following immunization), MAAEs (medically attended adverse events), AESIs (adverse events of special interest). |
From time of first study injection through Day 365.
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Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 3 doses
Časové okno: From time of first study injection through Day 365.
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Description of safety outcomes over 12 months post-vaccination including SAEs (serious adverse events), provincially reportable AEFIs (adverse events following immunization), MAAEs (medically attended adverse events), AESIs (adverse events of special interest). |
From time of first study injection through Day 365.
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Acceptability of vaccines as determined by participant-completed questionnaire after 2 doses
Časové okno: Days 56, 140, and 365
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Four 5 point likert scale type questions asking whether they would want to receive the vaccine again, recommend it to a friend, whether they were anxious about receiving it, and whether they would prefer a more painful injection if it conferred better protection. |
Days 56, 140, and 365
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Acceptability of vaccines as determined by participant-completed questionnaire after 3 doses
Časové okno: Days 28, 180
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Four 5 point likert scale type questions asking whether they would want to receive the vaccine again, recommend it to a friend, whether they were anxious about receiving it, and whether they would prefer a more painful injection if it conferred better protection. |
Days 28, 180
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Antibody to SARS-CoV-2 S and N, RBD after 3 doses
Časové okno: Days 180 and 365
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Assess durability of the immune responses in each study group over 12 months after the study vaccine. |
Days 180 and 365
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Pseudoneutralization assay, T cell testing, Antibody dependent cellular cytotoxicity after 3 doses
Časové okno: Day 365
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Further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365 |
Day 365
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Incidence of grade 3 solicited local and systemic adverse events, SAEs, AEFIs, MAAEs, AESIs in the 7 days following vaccine receipt after 4 doses
Časové okno: From time of first study injection through Day 365.
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Description of safety outcomes over 12 months post-vaccination including SAEs (serious adverse events), provincially reportable AEFIs (adverse events following immunization), MAAEs (medically attended adverse events), AESIs (adverse events of special interest). |
From time of first study injection through Day 365.
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Acceptability of vaccines as determined by participant-completed questionnaire after 4 doses
Časové okno: Days 28, 180
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Four 5 point likert scale type questions asking whether they would want to receive the vaccine again(Yes, definitely; Yes, probably; I don't know; No, probably not; No, definitely not), recommend it to a friend(Yes, definitely; Yes, probably; I don't know; No, probably not; No, definitely not), whether they were anxious about receiving it(Not at all; A little; Moderately; Very; Extremely), and whether they would prefer a more painful injection if it conferred better protection(Vaccine A; Vaccine B; No preference; Unsure/don't know). |
Days 28, 180
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Antibody to SARS-CoV-2 S and N, RBD after 4 doses
Časové okno: Days 180 and 365
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Assess durability of the immune responses in each study group over 12 months after the study vaccine. |
Days 180 and 365
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Antibody dependent cellular cytotoxicity after 4 doses
Časové okno: Day 365
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Further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365 |
Day 365
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Pseudoneutralization assay after 4 doses
Časové okno: Day 365
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Measuring the 50% Neutralization Titer to further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365 |
Day 365
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T cell testing after 4 doses
Časové okno: Day 365
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Measuring the number of T cells to further characterize the immune response to COVID-19 vaccine in schedules with homologous and heterologous third doses to day 365 |
Day 365
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Exploratory assessment of interval between dose 1 and 2 on immune response after 3 or 4 doses
Časové okno: From time of first study injection through Day 365.
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Assess the role of intervals between first and second doses of the primary immunization schedule, and between 2nd and 3rd doses, on immune responses after the third dose over the study period. |
From time of first study injection through Day 365.
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Joanne Langley, Dalhousie University/CIRN
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Infekce dýchacích cest
- Infekce
- RNA virové infekce
- Virová onemocnění
- Nemoci dýchacích cest
- Plicní onemocnění
- Pneumonie, virová
- Zápal plic
- Koronavirové infekce
- Infekce Coronaviridae
- Infekce Nidovirales
- COVID-19
- Organizace a správa
- Správa zdravotnických služeb
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Biologické faktory
- Biologické produkty
- Složité směsi
- Vakcíny
- Virové vakcíny
- Vakcíny mRNA
- Vakcíny na bázi nukleových kyselin
- Vakcíny, syntetické
- Rekombinantní proteiny
- Vakcíny na covid-19
- Antigeny
- Vakcíny, DNA
- BNT162 Vakcína
- 2019-NCOV vakcína mRNA-1273
- Chadox1 NCOV-19
- Schůzky a plány
Další identifikační čísla studie
- CT24
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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